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Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with systemic sclerosis diagnosed by 2013 ACR\EULAR classification criteria of systemic sclerosis
  • Patients' age >18
  • 25 rheumatoid arthritis patients as a control .

Exclusion Criteria:

-Overlap or mixed connective tissue diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    study group

    control group

    Arm Description

    Blood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum .Separated serum will be stored at < - 20c ( avoid repeated freeze - thaw cycles) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .

    Blood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum .Separated serum will be stored at < - 20c ( avoid repeated freeze - thaw cycles) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .

    Outcomes

    Primary Outcome Measures

    : To measure circulating Sirt 3 and Sirt 7 levels in patients with systemic sclerosis and their relation with different clinical manifestations
    the amount of Sirt 3 and Sirt 7 will be measured by ELISA
    Influence of Sirt 3 and Sirt 7 in fibrosis in Systemic sclerosis
    the amount of Sirt 3 and Sirt 7 will be measured by ELISA

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2020
    Last Updated
    September 18, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04303208
    Brief Title
    Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis
    Official Title
    Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.
    Detailed Description
    Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males. Sirtuins are a class of nicotinamide adenine dinucleotide-consuming enzymes that are implicated in numerous biological pathways . Sirtuins are considered among the most promising targets for modulating aging-associated cellular and molecular processes and disease pathologies , The majority of studies have shown decreased SIRT expression in tissues and fibroblasts from patients with SSc compared to controls and in experimental fibrosis in mice . Decreased SIRT3 levels and activity were observed in fibrotic areas of SSc and IPF lung tissues and SSc skin biopsies and explanted fibroblasts compared to controls , Wyman et al investigated the expression of all seven mammalian SIRTs in lung tissues and fibroblasts from patients with SSc and IPF and found a tendency for SIRTs to be decreased in patients with fibrosis compared to controls , with a particularly notable decline in SIRT7 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Sclerosis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Other
    Arm Description
    Blood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum .Separated serum will be stored at < - 20c ( avoid repeated freeze - thaw cycles) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .
    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    Blood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum .Separated serum will be stored at < - 20c ( avoid repeated freeze - thaw cycles) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .
    Intervention Type
    Procedure
    Intervention Name(s)
    Blood sample
    Intervention Description
    Blood sample ( 5 ml venous blood ) will be obtained under complete aseptic conditions from all eligible participants , using serum separator tube and allow samples to clot for 30 minutes before centrifugation for 15 minutes to obtain clear serum . Separated serum will be stored at < - 20c ( avoid repeated freeze - thaw cycles ) till assessment of Sirt 3 and Sirt 7 levels using Enzyme- linked immunosorbent assay (ELISA) method .
    Primary Outcome Measure Information:
    Title
    : To measure circulating Sirt 3 and Sirt 7 levels in patients with systemic sclerosis and their relation with different clinical manifestations
    Description
    the amount of Sirt 3 and Sirt 7 will be measured by ELISA
    Time Frame
    2 years
    Title
    Influence of Sirt 3 and Sirt 7 in fibrosis in Systemic sclerosis
    Description
    the amount of Sirt 3 and Sirt 7 will be measured by ELISA
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with systemic sclerosis diagnosed by 2013 ACR\EULAR classification criteria of systemic sclerosis Patients' age >18 25 rheumatoid arthritis patients as a control . Exclusion Criteria: -Overlap or mixed connective tissue diseases.

    12. IPD Sharing Statement

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    Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

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